A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma

Brief description of study

The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in
combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL)
and further explore schedule variations of NIR178 to optimize immune activation through
inhibition of A2aR.

Detailed Study Description

The study has four parts: part 1: Multi-arm Bayesian adaptive signal finding design in solid
tumors and diffuse large B cell lymphoma (DLBCL); part 2: NIR178 schedule exploration in
NSCLC; part 3: Further evaluation of intermittent dosing schedules of NIR178 in combination
with PDR001 in additional tumor types, if part 2 identifies an intermittent dosing schedule
of NIR178 as warranting further exploration; part 4: A separate safety run-in part will be
conducted in Japan in order to adequately characterize the safety and pharmacokinetic
profiles of NIR178 as a single-agent.

Parts 1, 2 and 4 will enroll in parallel. Part 3 will be opened based on the results from
part 2.

Patients enrolled in this study will receive NIR178 either BID continuously or based on the
assigned intermittent schedule within 60 minutes prior to PDR001 infusion. PDR001 will be
administered via IV infusion over 30 minutes once every 4 weeks. Each treatment cycle is 28
days. Patients enrolled in the Japanese safety run-in part will receive NIR178 as single
agent for the first cycle (28 days). If the patients complete cycle 1 without experiencing
DLTs, they will initiate combination therapy with PDR001 starting cycle 2 onwards, and
continue at the same dose of NIR178.

Patients will receive treatment with the combination until disease progression (assessed by
investigator per immune-related response criteria (irRC) or Cheson 2014, unacceptable
toxicity, death or discontinuation from study treatment for any other reason (e.g.,
withdrawal of consent, start of a new anti-neoplastic therapy or at the discretion of the
investigator), otherwise known as End of Treatment.